Den Europæiske Union - dansk - EMA (European Medicines Agency)

bayer ag - rivaroxaban - arthroplasty, replacement; venous thromboembolism - antitrombotiske midler - xarelto, co-gives sammen med acetylsalicylsyre (asa) alene eller sammen med asa plus clopidogrel eller ticlopidin, der er indiceret til forebyggelse af atherothrombotic hændelser hos voksne patienter efter en akut koronar syndrom (acs) med forhøjet kardiale biomarkører. xarelto, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. forebyggelse af venøs tromboembolisme (vte) hos voksne patienter, der gennemgår valgfri hofte- eller knæskifteoperation. behandling af dyb venøs trombose (dvt) og lungeemboli (pe), og forebyggelse af recidiverende dvt og pe i voksne. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - glecaprevir, pibrentasvir - hepatitis c kronisk - antivirale midler til systemisk anvendelse - maviret is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults and children aged 3 years and older. maviret coated granules is indicated for the treatment of chronic hepatitis c virus (hcv) infection in children 3 years and older.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

abacus medicine a/s - calciumcarbonat, cholecalciferol - tyggetabletter - 500 mg+10 mikrogram

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

2care4 aps - ciclosporin - kapsler, bløde - 100 mg

Den Europæiske Union - dansk - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - burosumab - hypophosphatemia, familial; hypophosphatemic rickets, x-linked dominant; osteomalacia - narkotika til behandling af knoglesygdomme - crysvita is indicated for the treatment of x-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. crysvita is indicated for the treatment of fgf23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - arsen trioxid - leukæmi, promyelocytisk, akut - antineoplastiske midler - arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory apl (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rarα) gene. svarprocenten af anden akut myeloid leukæmi undertyper til arsen trioxid har ikke været undersøgt.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

eurogenerics holdings b.v. - teriparatid - osteoporose - calciumhomeostase - qutavina is indicated in adults. behandling af osteoporose hos postmenopausale kvinder og hos mænd med øget risiko for brud. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. behandling af osteoporose, der er forbundet med vedvarende systemisk glukokortikoid behandling, kvinder og mænd med øget risiko for fraktur.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

theramex ireland limited - teriparatid - osteoporose - calciumhomeostase - livogiva is indicated in adults. behandling af osteoporose hos postmenopausale kvinder og hos mænd med øget risiko for brud. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. behandling af osteoporose, der er forbundet med vedvarende systemisk glukokortikoid behandling, kvinder og mænd med øget risiko for fraktur.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriparatid - osteoporose - calciumhomeostase - sondelbay is indicated in adults. behandling af osteoporose hos postmenopausale kvinder og hos mænd med øget risiko for brud. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. behandling af osteoporose, der er forbundet med vedvarende systemisk glukokortikoid behandling, kvinder og mænd med øget risiko for fraktur.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

baxter holding b.v. - pemetrexed disodium heptahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastiske midler - malignant pleural mesotheliomapemetrexed baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed baxter in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5. pemetrexed baxter is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5. pemetrexed baxter is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.